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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSENSITITRE
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameantimicrobial susceptability test system
Regulation Number866.1645
ApplicantTREK DIAGNOSTIC SYSTEMS, INC.
PMA NumberN50531
Date Received07/19/1978
Decision Date05/04/1979
Reclassified Date 09/13/2002
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S003 S004 S005 S006 S007 
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